Quality Engineer - CAPA Site Lead

Olympus Corporation of the Americas•Redmond, WA

25d•Hybrid

About The Position

The position ensures consistent oversight and execution of Corrective and Preventive Action (CAPA) processes across the organization, supporting compliance with regulatory requirements and quality standards. The role provides expertise in the full CAPA lifecycle, including issue identification, containment, risk assessment, root cause analysis, action planning, implementation, and verification of effectiveness, while integrating risk management principles and aligning with broader quality systems. The position serves as a key resource for regulatory and audit readiness, ensuring CAPAs are defensible and effectively closed. Additionally, the role drives cross-functional collaboration, facilitating structured problem-solving sessions, lessons learned, and continuous improvement initiatives across manufacturing, QA, QC, engineering, DA, R&D, PMS and supply chain functions. Through mentoring, coaching, and influencing without direct authority, the role strengthens analytical and systemic thinking within teams, promotes best practices, and fosters a culture of accountability and data-driven decision-making. The position also manages multiple CAPA projects, ensuring timely closure, effective prioritization based on risk, and adherence to defined timelines and metrics. This role requires strong expertise in electronic Quality Management Systems (eQMS) such as Agile, SAP, TrackWise, along with proficiency in data analytics tools including Excel, Power BI, and Minitab for trend analysis and tracking CAPA effectiveness. A thorough understanding of document control and change management processes is essential to ensure compliance and maintain quality system integrity. The position also emphasizes a metrics-driven and continuous improvement approach, including monitoring CAPA KPIs (e.g., on-time closure rate, recurrence rate, overdue CAPAs), identifying system-level trends, proposing proactive improvements, and integrating CAPA learnings into training programs and standard operating procedures to enhance overall process performance.

Requirements

Minimum of 7-9 years of experience in Quality, with 3-5 years leading CAPA or quality system.
Experience as QA Manager, Quality Engineer, Compliance Lead.
Strong communicator; able to work effectively with manufacturing, QA, QC, engineering, and supply chain.
Facilitate cross-functional “lessons learned” sessions to enhance record quality.
Partner with other sites and the Global CAPA CoE to identify and address systemic or recurring issues.
Builds accountability across teams and drives timely CAPA closure.
Able to influence behaviours and culture around continuous improvement.
Skilled in coaching others on CAPA principles and data-driven decision making.
Mentor investigators and approvers to strengthen analytical and systemic thinking capabilities.
Promote best practices and continuous learning.
Proficient in tracking CAPA timelines, deliverables, and metrics.
Ability to manage multiple CAPAs concurrently and prioritize based on risk.
Travel will be approximately 5%.

Nice To Haves

Bachelor of Science preferred.

Responsibilities

Lead Technical and monthly CAPA CNRB meetings.
Upskill, mentor and coach CAPA teams.
Facilitate Process and System Trainings on Site or virtual as required.
CAPA (Process) Approver reviewing CAPA content for quality and completeness.
Monitor site level CAPA performance and deliverables to improve consistency and execution across all events.
CAPA SME in QMR, CNRB, Data Analysis.
Deep understanding of CAPA process lifecycle - from issue identification, root cause analysis, action planning, implementation, and verification of effectiveness.
Strong grasp of risk management principles and how CAPA integrates with quality systems (e.g., change control, deviations, complaints, audits).
Proficiency with RCA tools (5 Whys, Fishbone (Ishikawa) diagrams or other structured problem-solving methodologies).
Skilled at facilitating cross-functional RCA sessions.
Knowledge of applicable regulations and standards, such as: FDA 21 CFR Parts 210, 211, 820 or ISO 9001 / ISO 13485.
Experience with audit and inspection readiness; able to defend CAPAs and demonstrate robust closure.